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510(k) K170239

Leica FL560 by Leica Microsystems (Schweiz) AG — Product Code IZI

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 5, 2017
Date Received
January 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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